External Causes of Morbidity and MortalityNCT01472679
Body Composition: a Predictor of Mortality in Subjects Over 65 Years
An observational study of External Causes of Morbidity and Mortality, run by Genton Graf Laurence at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate whether body composition is associated with a higher risk of mortality in subjects ≥ 65 years. Read more about this study
- Who is it for?
- Ages 65 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- External Causes of Morbidity and Mortality
- How many people
- 6,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 110 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: This is a historical cohort study of prospectively collected measurements of body composition performed by bioelectrical impedance analysis, between 1990 and 2011.
Who may be able to join
- All subjects ≥ 65 years included in previous studies on body composition by bioelectrical impedance analysis performed in the Nutrition Unit since 1990 until December 2011.
- All patients ≥ 65 years who had a measurement of body composition by bioelectrical impedance analysis performed in clinical routine by the Nutrition Unit and the dietitians of the University Hospital of Geneva since 1990 until December 2011, while hospitalized or not.
Who cannot join
- Subjects living in another country than Switzerland at time of body composition measurement
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate whether body composition is associated with a higher risk of mortality in subjects ≥ 65 years.
Read the detailed description
Study centre: University Hospitals of Geneva Study type: retrospective study Study duration (anticipated): 1 year for collection of data(1.10.2011-1.12.2012)and 3 months for statistical analysis and writing, leading to the completion of the study by march 2013 Study hypothesis: A low fat-free mass (FFM) and a high fat mass (FM) are associated with a higher risk of mortality in subjects ≥ 65 years.
Aims: The primary objective is to evaluate the relationship between body composition and mortality in men and women ≥ 65 years, while taking into account co-morbidities. The secondary objectives are to compare this relationship a) with the relationship of body mass index (BMI) and mortality, b) with the relationship of body composition changes and mortality, c) between healthy subjects and subgroups of patients with chronic diseases Methods: Included are all subjects who had a measurement of body composition by bioelectrical impedance analyses, performed in the HUG from 1990 until december 2011. Excluded are subjects living abroad. Body composition measurements will be retrieved from DPI and 4D which preceded the use of DPI in nutrition and is presently only used for research. Diseases and specific laboratory values at time of body composition measurement will be retrieved simultaneously. Mortality will be retrieved from the population registers for death.
Statistics: The relationship between body composition and mortality, in the total population and subgroups of patients with chronic diseases, will be evaluated by Cox regression, adjusted for age, gender and co-morbidities. The variance of mortality (adjusted R2) related to FFM will be compared to that related to BMI and FFM loss.
- Keywords
- fat mass, fat free mass, body mass index
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Report if the subject died or not until 31st December 2011
Measured: Mortality from 1 January 1990 to 31 December 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startOct 2016
- Primary completionMay 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for External Causes of Morbidity and MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genton Graf Laurence
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Genton Graf Laurence, University Hospital, Geneva
- Investigators
- Laurence Genton, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472679
- Sponsor's protocol ID
- 11-161R
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2011
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Graf CE, Herrmann FR, Genton L. Relation of Disease with Standardized Phase Angle among Older Patients. J Nutr Health Aging. 2018;22(5):601-607. doi: 10.1007/s12603-018-1034-4.
PubMed 29717760Graf CE, Karsegard VL, Spoerri A, Makhlouf AM, Ho S, Herrmann FR, Genton L. Body composition and all-cause mortality in subjects older than 65 y. Am J Clin Nutr. 2015 Apr;101(4):760-7. doi: 10.3945/ajcn.114.102566. Epub 2015 Feb 11.
PubMed 25833973
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition: a Predictor of Mortality in Subjects Over 65 Years
- ClinicalTrials.gov ID
- NCT01472679
- Acronym / sponsor ID
- 11-161R
- Keywords
- fat mass, fat free mass, body mass index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Genton Graf LaurenceUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether body composition is associated with a higher risk of mortality in subjects ≥ 65 years.
Detailed description
Study centre: University Hospitals of Geneva Study type: retrospective study Study duration (anticipated): 1 year for collection of data(1.10.2011-1.12.2012)and 3 months for statistical analysis and writing, leading to the completion of the study by march 2013 Study hypothesis: A low fat-free mass (FFM) and a high fat mass (FM) are associated with a higher risk of mortality in subjects ≥ 65 years.
Aims: The primary objective is to evaluate the relationship between body composition and mortality in men and women ≥ 65 years, while taking into account co-morbidities. The secondary objectives are to compare this relationship a) with the relationship of body mass index (BMI) and mortality, b) with the relationship of body composition changes and mortality, c) between healthy subjects and subgroups of patients with chronic diseases Methods: Included are all subjects who had a measurement of body composition by bioelectrical impedance analyses, performed in the HUG from 1990 until december 2011. Excluded are subjects living abroad. Body composition measurements will be retrieved from DPI and 4D which preceded the use of DPI in nutrition and is presently only used for research. Diseases and specific laboratory values at time of body composition measurement will be retrieved simultaneously. Mortality will be retrieved from the population registers for death.
Statistics: The relationship between body composition and mortality, in the total population and subgroups of patients with chronic diseases, will be evaluated by Cox regression, adjusted for age, gender and co-morbidities. The variance of mortality (adjusted R2) related to FFM will be compared to that related to BMI and FFM loss.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This is a historical cohort study of prospectively collected measurements of body composition performed by bioelectrical impedance analysis, between 1990 and 2011.
Key inclusion criteria (2 listed)
- All subjects ≥ 65 years included in previous studies on body composition by bioelectrical impedance analysis performed in the Nutrition Unit since 1990 until December 2011.
- All patients ≥ 65 years who had a measurement of body composition by bioelectrical impedance analysis performed in clinical routine by the Nutrition Unit and the dietitians of the University Hospital of Geneva since 1990 until December 2011, while hospitalized or not.
Key exclusion criteria (1 listed)
- Subjects living in another country than Switzerland at time of body composition measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Mortality from 1 January 1990 to 31 December 2011
Report if the subject died or not until 31st December 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 29717760Graf CE, Herrmann FR, Genton L. Relation of Disease with Standardized Phase Angle among Older Patients. J Nutr Health Aging. 2018;22(5):601-607. doi: 10.1007/s12603-018-1034-4.
- Derived from this study: PubMed 25833973Graf CE, Karsegard VL, Spoerri A, Makhlouf AM, Ho S, Herrmann FR, Genton L. Body composition and all-cause mortality in subjects older than 65 y. Am J Clin Nutr. 2015 Apr;101(4):760-7. doi: 10.3945/ajcn.114.102566. Epub 2015 Feb 11.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Genton, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of External Causes of Morbidity and Mortality, run by Genton Graf Laurence at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Mortality from 1 January 1990 to 31 December 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01472679, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.